Canesten HC 1% w/w + 1% w/w Cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOTRIMAZOLE, HYDROCORTISONE

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

D01AC20

INN (International Name):

CLOTRIMAZOLE 10 mg HYDROCORTISONE 10 mg

Pharmaceutical form:

CREAM

Composition:

CLOTRIMAZOLE 10 mg HYDROCORTISONE 10 mg

Prescription type:

POM

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-03-09

Patient Information leaflet

BCH22002
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CANESTEN HC 1% W/W + 1% W/W CREAM
clotrimazole/hydrocortisone
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1. What is Canesten HC Cream and what is it used for?
2. What you need to know before you use Canesten HC Cream
3. How to use Canesten HC Cream
4. Possible side effects
5. How to store Canesten HC Cream
6. Contents of the pack and other information
1. WHAT IS CANESTEN® HC CREAM AND WHAT IS IT USED FOR?
Canesten HC Cream is used to treat fungal skin infections when there
are additional symptoms of
inflammation (such as swelling, redness and itching). Canesten HC
treats the fungal skin
infection and reduces the swelling and itching caused by it.
Canesten HC Cream is used for the treatment of infection and
irritation of the vulva or end of the
penis (glans) caused by thrush. It is also used to treat nappy rash
and fungal infection of the breast
fold (intertrigo), as well as infections such as ringworm and
athlete’s foot.
The active substances in Canesten HC Cream are clotrimazole and
hydrocortisone. Clotrimazole
belongs to a group of medicines called imidazoles, which destroy the
fungi and some bacteria that
cause skin infections. Hydrocortisone is a mild steroid which reduces
swelling, redness and
itching associated with inflammation of the skin.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN® HC CREAM
DO NOT USE CANESTEN® HC CREAM:
•
If you (or your baby if treating nappy rash) are allergic
(hypersensitive) to clotrimazole,
hydrocortisone or any of the other ingre

Summary of Product characteristics

1
BCH22002
RESTRICTED
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten HC 1% w/w + 1% w/w Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 10mg clotrimazole (1% w/w) and 11.2mg
hydrocortisone acetate (equivalent to
10mg hydrocortisone 1% w/w).
Excipient with known effecteach gram of cream contains 100 mg
cetostearyl alcohol and 20 mg benzyl
alcohol.
For a full list of excipients, see 6.1
3.
PHARMACEUTICAL FORM
Cream.
A white to pale yellow cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten HC Cream is a combination of an antifungal and a
corticosteroid, both absorbable through broken
skin. It is indicated for the topical treatment of skin infections due
to superficial dermatophytes, yeasts,
moulds and other fungi sensitive to clotrimazole where co-existing
symptoms of inflammation, e.g. itching,
require rapid relief.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Canesten HC Cream should be thinly and evenly applied to the affected
area twice daily and rubbed in
gently.
Treatment should be continued for no more than 7 days.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
The following contra-indications apply to the hydrocortisone
component: specific bacterial skin diseases
(syphilis, tuberculosis), chicken pox, vaccination reactions, perioral
dermatitis, viral skin diseases (e.g.
herpes simplex, rosacea, shingles), use on broken skin, acne.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
All possibly infected areas should be treated at the same time.
Because of its corticosteroid content, Canesten HC should not be
applied:
•
To large areas (more than 10% of the body surface)
•
In long term continuous therapy
•
Under occlusive dressing, particularly in infants and children,
because of the possibility of
2
BCH22002
RESTRICTED
adrenocortical suppression.
This product contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact dermatitis) and
benzyl alcohol w